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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 42MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
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SMITH & NEPHEW ORTHOPAEDICS LTD RESURFACING FEMORAL HEAD 42MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING Back to Search Results
Catalog Number 74121142
Device Problems Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Injury (2348); Ambulation Difficulties (2544); Metal Related Pathology (4530)
Event Date 10/27/2014
Event Type  Injury  
Manufacturer Narrative
All of the implanted devices were used in treatment.As of today, additional information has been requested for this complaint but have not become available.As no device part and batch numbers were provided for investigation, a manufacturing record review, complaint history review, device labelling review & risk management could not be performed.If more information is received, the tasks will be reopened and completed.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
 
Event Description
Plaintiff underwent medically-indicated revision of the bhr right hip implants on (b)(6) 2014.The patient revision surgery was performed due to severe pain, failed right hip resurfacing, elevated levels of cobalt and chromium, stiffness, loss of mobility, and metallosis.The patient outcome is unknown.
 
Manufacturer Narrative
Sections a2, a3, b5, b6, d1, d3, d4, g4, h4 and h6 were updated according to the new information received.Internal complaint reference number: (b)(4).
 
Event Description
Plaintiff underwent medically-indicated revision of the bhr right hip implants on (b)(6) 2014.The patient revision surgery was performed due to severe pain, failed right hip resurfacing, elevated levels of cobalt and chromium, stiffness, loss of mobility, and metallosis.Pain was also treated on (b)(6) 2014 with a cortisone injection.One day after the smith and nephew devices were explanted, the patient suffered from hypotension and tachycardia and was treated with medications.The patient was discharged after 3 days in stable condition.
 
Manufacturer Narrative
H3, h6: it was reported that a right hip revision surgery was performed.The bhr acetabular cup and the femoral head were explanted.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the historical complaints data for the acetabular cup was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Other similar complaints were identified to involve this batch and the part number and the reported failure mode.However, as the device is no longer sold, no action is to be taken.A review of the historical complaints data for the femoral head was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Other similar complaints were identified to involve this batch and the part number and the reported failure mode.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.The available medical documents were reviewed.It is unknown to what extent the patient¿s fall had on her pain and clinical status.The reported pain, stiffness, loss of mobility, elevated metal ions, and intraoperative findings of osteolysis, synovial cyst, and stained green tissue may be consistent with findings associated with metallosis.However, the root cause of the reported metallosis cannot be confirmed nor can it be concluded that the clinical reactions are associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without the return of the actual devices or further information we cannot further investigate or confirm the reported complaint, or the details supplied in this complaint.The investigation remains inconclusive, and a definitive root cause cannot be determined.Additionally, specific factors known to contribute to the alleged fault cannot be provided due to the insufficient information.If the products or additional information become available in the future, this case will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.
 
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Brand Name
RESURFACING FEMORAL HEAD 42MM
Type of Device
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
leamington spa CV31 3HL
UK  CV31 3HL
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS LTD
aurora house
spa park
CV31 3HL
UK   CV31 3HL
Manufacturer Contact
holly topping
7000 west william cannon drive
spa park
austin, TX 78735
5123913905
MDR Report Key10554651
MDR Text Key207563476
Report Number3005975929-2020-00342
Device Sequence Number1
Product Code NXT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/29/2011
Device Catalogue Number74121142
Device Lot Number70348
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/30/2006
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age46 YR
Patient SexFemale
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